Duns Number:658608864
Device Description: The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / CM, FA, PU and SP series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS, EMS, IF, and PGS.
Catalog Number
-
Brand Name
WELL-LIFE
Version/Model Number
CM-5050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LIH
Product Code Name
Interferential Current Therapy
Public Device Record Key
fb1e5c6d-966e-4988-aba2-1d9b83a01f77
Public Version Date
October 19, 2020
Public Version Number
5
DI Record Publish Date
May 02, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |